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A Study to Evaluate The Pharmacokinetics Of Crizotinib (PF-02341066) In Subjects With Impaired Renal Function

Last updated on May 9, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Anaheim, California, 92801 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Renal Impairment
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-75 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

All Subjects

- Healthy male and/or female of non childbearing potential subjects between the ages of
18 and 65 years, inclusive ('healthy' is defined as no clinically relevant
abnormalities identified by a detailed medical history, full physical examination,
including blood pressure and pulse rate measurement, 12 lead ECG, and clinical
laboratory tests).

- Body Mass Index (BMI) of 18 to 40 kg/m2 inclusive; and a total body weight >50 kg
(>110 lbs).

Subjects with Normal Renal Function (Group 1)

- Normal renal function (CLcr =>90 mL/min) during the screening period.

- Matched 1-to-1 to subjects in Group 2 with respect to age (+/-5 years), weight (+/-10
kg), gender, and race according to protocol.

Subjects with Severe Renal Impairment (Groups 2)

- Good general health commensurate with the population with chronic kidney disease.

- Severe renal impairment (CLcr

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

All Subjects

- Renal allograft recipients.

- Any condition possibly affecting drug absorption.

- 12 lead ECG demonstrating QTc >470 msec at screening.

- Urinary incontinence without catheterization.

- A positive urine drug screen.

- History of regular alcohol consumption.

- Treatment with an investigational drug within 30 days (or as determined by the local
requirement, whichever is longer) or 5 half lives preceding the first dose of study
medication.

- Pregnant or nursing females; females of childbearing potential, including those with
tubal ligation.

- Blood donation of approximately 1 pint (500 mL) within 56 days prior to dosing.

Subjects with Severe Renal Impairment (Groups 2)

- Subjects with any significant hepatic, cardiac or pulmonary disease (apart from stable
ischemic heart disease), or subjects who are clinically nephrotic.

- Subjects requiring hemodialysis.

- Subjects with strict fluid restriction (ie,

- Significant bleeding diathesis which could preclude multiple venipuncture.

- Use of food or drugs that are CYP3A4 inhibitors and inducers.

- Herbal supplements and hormone replacement therapy must be discontinued 28 days prior
to the first dose of trial medication

- Concurrent use of drugs that are CYP3A4 substrates with narrow therapeutic indices.

NCT01419041
Pfizer
Completed
A Study to Evaluate The Pharmacokinetics Of Crizotinib (PF-02341066) In Subjects With Impaired Renal Function

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A Study to Evaluate The Pharmacokinetics Of Crizotinib (PF-02341066) In Subjects With Impaired Renal Function
A Phase I, Single Dose, Parallel-Group Study To Evaluate The Pharmacokinetics Of Crizotinib (PF-02341066) In Subjects With Impaired Renal Function
The present study is being conducted to evaluate whether or not severe renal impairment has an effect on crizotinib Pharmacokinetics.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Renal Impairment
  • Drug: crizotinib
    Single-dose oral 250 mg crizotinib in subjects with normal renal function (CLcr =>90 mL/min)
  • Drug: crizotinib
    Single-dose oral 250 mg crizotinib in subjects with severe renal impairment (CLcr <30 mL/min)
  • Arm A
    CLCR: Creatinine clearance
    Intervention: Drug: crizotinib
  • Arm B
    CLCR: Creatinine clearance
    Intervention: Drug: crizotinib
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
August 2012
August 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

All Subjects

  • Healthy male and/or female of non childbearing potential subjects between the ages of 18 and 65 years, inclusive ('healthy' is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG, and clinical laboratory tests).
  • Body Mass Index (BMI) of 18 to 40 kg/m2 inclusive; and a total body weight >50 kg (>110 lbs).

Subjects with Normal Renal Function (Group 1)

  • Normal renal function (CLcr =>90 mL/min) during the screening period.
  • Matched 1-to-1 to subjects in Group 2 with respect to age (+/-5 years), weight (+/-10 kg), gender, and race according to protocol.

Subjects with Severe Renal Impairment (Groups 2)

  • Good general health commensurate with the population with chronic kidney disease.
  • Severe renal impairment (CLcr<30 mL/min) during the screening period.

Exclusion Criteria:

All Subjects

  • Renal allograft recipients.
  • Any condition possibly affecting drug absorption.
  • 12 lead ECG demonstrating QTc >470 msec at screening.
  • Urinary incontinence without catheterization.
  • A positive urine drug screen.
  • History of regular alcohol consumption.
  • Treatment with an investigational drug within 30 days (or as determined by the local requirement, whichever is longer) or 5 half lives preceding the first dose of study medication.
  • Pregnant or nursing females; females of childbearing potential, including those with tubal ligation.
  • Blood donation of approximately 1 pint (500 mL) within 56 days prior to dosing.

Subjects with Severe Renal Impairment (Groups 2)

  • Subjects with any significant hepatic, cardiac or pulmonary disease (apart from stable ischemic heart disease), or subjects who are clinically nephrotic.
  • Subjects requiring hemodialysis.
  • Subjects with strict fluid restriction (ie, <1500 mL/24 hours).
  • Significant bleeding diathesis which could preclude multiple venipuncture.
  • Use of food or drugs that are CYP3A4 inhibitors and inducers.
  • Herbal supplements and hormone replacement therapy must be discontinued 28 days prior to the first dose of trial medication
  • Concurrent use of drugs that are CYP3A4 substrates with narrow therapeutic indices.
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01419041
A8081020
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
September 2012

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]



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